Risperidone Tablets

RISPERIDONE GENEIC ® (risperidone) is used for the treatment
of schizophrenia in adults and adolescents ages 13-17 years.

RISPERIDONE GENEIC ® (risperidone) is used alone or in
combination with other medicines (valproate or lithium) in adults for the
short-term treatment of bipolar mania; or alone in adults, children and
adolescents ages 10-17 years for the short-term treatment of bipolar
mania.

RISPERIDONE GENEIC ® (risperidone) is used for the treatment
of irritability associated with autistic disorder in children and
adolescents ages 5-16 years.

IMPORTANT SAFETY INFORMATION FOR RISPERIDONE GENEIC ®

Elderly Patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death compared to
placebo. RISPERIDONE GENEIC ® (risperidone) is not approved for
the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal
side effect reported with RISPERIDONE GENEIC ® and similar
medicines. Call your doctor immediately if the person being treated
develops symptoms such as high fever; stiff muscles; shaking; confusion;
sweating; changes in pulse, heart rate, or blood pressure; or muscle pain
and weakness. Treatment should be stopped if the person being treated has
NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side
effect reported with RISPERIDONE GENEIC ® and similar
medications. TD includes uncontrollable movements of the face, tongue, and
other parts of the body. The risk of developing TD and the chance that it
will become permanent is thought to increase with the length of therapy
and the overall dose taken by the patient. This condition can develop
after a brief period of therapy at low doses, although this is much less
common. There is no known treatment for TD, but it may go away partially
or completely if therapy is stopped.

RISPERIDONE GENEIC ® and similar medications can raise the
blood levels of a hormone known as prolactin, causing a condition known as
hyperprolactinemia. Blood levels of prolactin remain elevated with
continued use. Some side effects seen with these medications include the
absence of a menstrual period; breasts producing milk; the development of
breasts by males; and the inability to achieve an erection. The connection
between prolactin levels and side effects is unknown.

High blood sugar and diabetes have been reported with
RISPERIDONE GENEIC ® and similar medications. If the person
being treated has diabetes or risk factors such as being overweight or a
family history of diabetes, blood sugar testing should be performed at
the beginning and throughout treatment. Complications of diabetes can
be serious and even life threatening. If signs of high blood sugar or
diabetes develop, such as being thirsty all the time, going to the
bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERIDONE GENEIC ® should be used cautiously in people
with a seizure disorder, who have had seizures in the past, or who have
conditions that increase their risk for seizures.

Some people taking RISPERIDONE GENEIC ® may feel faint or
lightheaded when they stand up or sit up too quickly. By standing up or
sitting up slowly and following your healthcare professional's dosing
instructions, this side effect may be reduced or it may go away over time.

Extrapyramidal Symptoms (EPS) are usually persistent movement
disorders or muscle disturbances, such as restlessness, tremors, and
muscle stiffness. If you observe any of these symptoms, talk to your
healthcare professional.

Some medications interact with RISPERIDONE GENEIC ® . Please
inform your healthcare professional of any medications or supplements that
you are taking. Avoid alcohol while taking RISPERIDONE GENEIC ®
.

Inform your healthcare professional if you are pregnant or if you are
planning to get pregnant while taking RISPERIDONE GENEIC ® .

RISPERIDONE GENEIC ®
may affect alertness and motor skills; use caution until the effect of
RISPERIDONE GENEIC is known.

Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.